Metacognitive Self-regulated Learning and Sensory Integrative Approaches for Children With Autism Spectrum Disorders

Autism Spectrum Disorder Clinical Trial

Official title:

Metacognitive Self-regulated Learning and Sensory Integrative Approaches for Children With Autism Spectrum Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02496819
• Other study ID #: SR-Autism
• Status: Completed
• Phase: N/A
• First received: June 26, 2015
• Last updated: November 2, 2017
• Start date: June 2015
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: University of Western Sydney
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Children with Autism Spectrum Disorder (ASD) are increasing each year. There are about 1 in 160 children for the age group of 6-12 years old in Australia are diagnosed with ASD. Children with ASD have impairment in two common areas including: i) social and communication and ii) repetitive and stereotypical patterns of behaviours. These common features result in behavioural problems which negatively impact children's participation in school, activities of daily living and social engagement.

Therefore, there is a need for effective interventions to overcome the behavioural problems in children with ASD.

The purpose of the study is to investigate the effect of sensory integration (SI) and self-regulated learning versus an activity-based control programme in reducing behavioural problems in children with ASD that interfere with their daily livings, school, and social engagement.

The study will adopt a randomized controlled trial design with three intervention groups: I) self-regulated learning, II) sensory integration and III) activity-based intervention as the control group.

Description:

Children with Autism Spectrum Disorder (ASD) are commonly associated with behavioural problems which may negatively impact on their participation in school, activities of daily livings and social engagement. In order to minimise the impact on the daily functioning of these children, overcoming the behavioural problems in these children is essential.

Two intervention approaches will be used in this study. These are i) self-regulated learning and ii) sensory integration. Sensory integration is commonly used for children with developmental problems. Self-regulated learning has been used to promote children's self-directed learning and in people with brain injuries.

However, the evidence towards the effectiveness of these two interventions in alleviating the effects of behavioural problems on participation in school, daily and social activities for children with ASD is limited and inconclusive.

Self-regulated learning theory:

The origin of self-regulated learning approach came from Albert Bandura's social cognitive theory. The theory states that intervention affects one's learning by modifying the personal, environmental and behavioural factors. The personal factor refers to one's beliefs and attitudes. The environment factor comprises of feedback, instructions, information gathered from teachers or instructors and also from the assistance of parents and peers. The behavioural factor includes past performance that are socially unacceptable. The key of self-regulated learning is to ensure that children make use of a cognitive strategy to facilitate behaviour learning by helping them to bring problems and solutions towards own consciousness. Several studies had used self-regulated learning in children and adults population. It was found a significant improvement in task performance for children with Attention Deficit Hyperactive Disorders (ADHD). The positive effect was also shown in another study showing improvements in performance measures of reading and intelligence quotient among children with moderate learning disabilities. Similar results were also seen in adults with brain injury in various studies. They suggested that self-regulated learning could enhance the active learning of participants.

Children with ASD were reported to commonly associate with self-regulation problems affecting their behaviour and learning ability. However, there is no study using self-regulated learning for this group of children to alleviate the effect of behavioural problems on their school, daily and social participation.

Sensory integration intervention theory:

Sensory integration theory was developed in 1960s and 1970s. The theory was developed to target on the neurological processing of sensory information. The theory suggests that purposeful behaviours may be interrupted when there is an interference of neurological processing and integration of sensory information. Sensory integration interventions have been widely used in varieties of settings among children with development problems. However, despite the vast amount of literature that exists on the effectiveness of sensory integration intervention, the overall evidence on the effectiveness on children with ASD and behavioural problems remains inconclusive. Some studies showed that sensory integration was an effective intervention given a positive result, but others showed no benefit or inconclusive findings.

Studies previously used sensory integration intervention seemed not using the fidelity measures in the intervention design to ensure that the intervention met the requirement of sensory integration theory. This could be one of the reasons for the inconclusive finding made on its effectiveness. Furthermore, most of the studies used a single-case study design with small sample sizes. In addition, previous studies using sensory integration did not focus on alleviating the effects of behavioural problems on function in the daily livings, school and social engagement for children with ASD.

This study, will therefore, adopt a randomised controlled trial (RCT) design to investigate the effect of sensory integration and self-regulated learning interventions (comparing with activity-based control intervention) in reducing the effects of behavioural problems on daily living, school and social engagement in children with ASD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Diagnosed with ASD meeting the requirements of the Diagnostic and Statistical Manual of Mental Disorders without dual diagnoses such as physical disabilities

• Overall score = 70 in Part I and Part II of the Vineland Adaptive Behaviour Scales (VABS-II) (2nd ed.). These parts of the scale will assess:.

• Problem behaviours Part I (internalizing, externalizing, other behaviours): 36 items

• Problem behaviours Part II (critical items): 14 items

• Have an IQ greater than 50. This is indicative of a normal intelligence quotient (IQ) to moderate grade intellectual disability. This is required so they are able to follow verbal instructions.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Intervention

Other:
• Meta-cognitive self-regulated learning intervention
It is a 12-week intervention programme with one 60 minutes sessions per week.
• Sensory integration intervention
It is a 12-week intervention programme with one 60 minutes sessions per week.
• Activity-based intervention
It is a 12-week intervention programme with one 60 minutes sessions per week.

Locations

Country	Name	City	State
Malaysia	National University of Malaysia	Bangi	Selango

Sponsors (2)

Lead Sponsor	Collaborator
University of Western Sydney	National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adaptive behaviour on the Vineland Adaptive Behaviour Scales - change from baseline after the intervention		Baseline and after the intervention (12 weeks)
Primary	Adaptive behaviour on the Vineland Adaptive Behaviour Scales - change from baseline at one month after the intervention completed		Baseline and one month after the intervention completed (16 weeks)
Primary	Executive function behaviours on the Behaviour Rating Inventory of Executive Function - change from baseline after the intervention		Baseline and after the intervention (12 weeks)
Primary	Executive function behaviours on the Behaviour Rating Inventory of Executive Function - change from baseline at one month after the intervention completed		Baseline and one month after the intervention completed (16 weeks)
Primary	School-related task performance on the School Function Assessment - change from baseline after the intervention		Baseline and after the intervention (12 weeks)
Primary	School-related task performance on the School Function Assessment - change from baseline at one month after the intervention completed		Baseline and one month after the intervention completed (16 weeks)
Primary	Social skills on the Walker Mc-Connell scale - change from baseline after the intervention		Baseline and after the intervention (12 weeks)
Primary	Social skills on the Walker Mc-Connell scale - change from baseline at one month after the intervention completed		Baseline and one month after the intervention completed (16 weeks)
Secondary	Sensory processing difficulties on the Sensory Processing Measures - change from baseline after the intervention		Baseline and after the intervention (12 weeks)
Secondary	Sensory processing difficulties on the Sensory Processing Measures - change from baseline at one month after the intervention completed		Baseline and one month after the intervention completed (16 weeks)
Secondary	Sensory processing patterns and effects on functional performance on the Sensory Profile - change from baseline after the intervention		Baseline and after the intervention (12 weeks)
Secondary	Sensory processing patterns and effects on functional performance on the Sensory Profile - change from baseline at one month after the intervention completed		Baseline and one month after the intervention completed (16 weeks)